Use of tAN® in Alcohol Withdrawal Management
ConditionAlcohol Withdrawal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorErin Deneke
About this trial
This research study is being conducted to learn if Transcutaneous Auricular Neurostimulation (tAN®) may be effective in treating alcohol withdrawal syndrome. Transcutaneous Auricular Neurostimulation (tAN®) works by delivering small electrical stimulations to the Vagus and Trigeminal nerves. This study will be conducted over the course of five days. Participants will be enrolled within 24 hours of entering treatment for alcohol withdrawal management. A total of 60 individuals will be enrolled and randomly assigned to either active (treatment with the device + treatment as usual) or sham (treatment as usual) group. Data will be collected on alcohol craving, use of comfort medications, sleep, and mood.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18 years old to 65 years old
Entering an inpatient substance use treatment program for alcohol withdrawal management.
Score a 27 or higher on the WHO-ASSIST V3.0
Is proficient in English
Disqualifiers
Age < 18 or > 65
Requires medical tapering from benzodiazepines or opioids.
Has a history of epileptic seizures or seizures due to alcohol withdrawal.
Has a cardiac pacemaker, cochlear prosthesis, neurostimulator or other device for which tAN® would be contraindicated.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Auricular Neurostimulation (tAN)
DeviceTranscutaneous Auricular stimulation will be delivered using the Spark Biomedical Sparrow Link pulse generator with Sparrow Ascent earpieces. The Sparrow Link generator is based on FDA-cleared predicate Sparrow Ascent.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active Transcutaneous Auricular Neurostimulation (tAN)Experimental treatment 1 intervention
Group B: Sham Transcutaneous Auricular Neurostimulation (tAN)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical Institute Withdrawal Assessment Scale, Revised (CIWA-Ar) score
Linear mixed effects models for repeated measurements will be used to evaluate the difference in changes in these primary outcomes between treatment and sham group. Mixed models take advantage of multiple measures from each individual, allowing for effects both between individuals and within each individual (e.g., across time). The CIWA-Ar is a 10-item scale measuring symptoms of alcohol withdrawal. The scores can range between 0-67. The total score is the sum of all scale items. Scores between 0-9 indicate absent to minimal withdrawal, Scores 10-19 indicate mild to moderate withdrawal and scores greater than 20 indicate severe withdrawal.
Time frame
Baseline to end of study day 52
Amount of comfort medications utilized
Medications such as ibuprofen, Librium, lorazepam, promethazine, loperamide, and acetaminophen are often used to treat alcohol withdrawal. A t-test will be utilized to compare medication usage between active and sham group.
Time frame
Baseline to end of study day 5Secondary outcomes
1
Change in ambient alcohol craving
Change in ambient alcohol craving will be measured using a 0-100 Visual Analog Scale (VAS) delivered by smartphone using Ecological Momentary Assessment (EMA) delivered 4 times per day. EMA will be analyzed as a mixed model in the regression framework and will test effects of treatment status as between-group differences
Time frame
Baseline to end of study day 52
Change in objective sleep
Objective sleep will be measured using wrist actigraphy. Analyses of actigraphy data will examine the effect of time (i.e., study day) to identify differences across condition in the amount of sleep (i.e. minutes).
Time frame
Baseline to end of study day 53
Change in subjective sleep
Subjective sleep will be measured using EMA. Analyses of EMA data will examine the effect of time (i.e., study day) to identify differences across condition in the quality of sleep.
Time frame
Baseline to end of study day 5Other outcomes
1
Change in mood
The impact of the Sparrow® Link treatment on mood will be primarily measured using EMA assessment and will be modeled using linear mixed models in the multilevel modeling (MLM) framework.
Time frame
Baseline to end of study day 5Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Erin Deneke
Lead sponsor
Caron Treatment Centers
Sponsor institution
Source ClinicalTrials.gov